Clearance Summary
SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F received FDA 510(k) clearance under submission number K894168, sponsored by Baxter Healthcare Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1989-11-27.
- Submission: K894168
- Applicant / Sponsor: Baxter Healthcare Corp
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 1989-11-27
Classification & Regulation
This clearance is catalogued under FDA product code DQO and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.